BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1020754 · Received March 17, 2008

    Report

    Report Number
    9617604-2008-00057
    Event Type
    Malfunction
    Date Received
    March 17, 2008
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL - OTHER: SMITHS MEDICAL'S INVESTIGATION INTO THIS EVENT IS VERY LIMITED AS THE USER FACILITY DID NOT RETAIN THE LOT # OR THE SAMPLE INVOLVED IN THE EVENT. THEY DID GIVE A POSSIBLE LOT # AND THE MFG RECORDS WERE REVIEWED AND NO PROBLEMS WERE NOTED DURING MFR AND WE DID NOT RECEIVE ANY OTHER REPORTS ON THE POSSIBLE LOT GIVEN. WITHOUT THE SAMPLE, THERE IS NO WAY TO DETERMINE IF THIS EVENT WAS DUE TO INCORRECT SETUP, IMPROPER MAINTENANCE OF THE HARDWARE, OR TO A DEVICE MALFUNCTION. THIS REPORT HAS BEEN LOGGED FOR TRENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1